FDA Orange Book · active-ingredient family
Erythromycin stearate
Erythromycin stearate is approved in 15 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERYTHROMYCIN STEARATE | ANI PHARMS | ANDA 063179 | — | May 15, 1990 | |
| BRISTAMYCIN | BRISTOL | ANDA 061304 | — | Approved Prior to Jan 1, 1982 | |
| BRISTAMYCIN | BRISTOL | ANDA 061887 | — | Approved Prior to Jan 1, 1982 | |
| ERYPAR×2 | PARKE DAVIS | ANDA 062032 | — | Approved Prior to Jan 1, 1982 | |
| ERYPAR | WARNER CHILCOTT | ANDA 062322 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROCIN STEARATE×3 | AZURITY | ANDA 060359 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE×2 | ANI PHARMS | ANDA 061461 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE | ANI PHARMS | ANDA 061591 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE×2 | LEDERLE | ANDA 062089 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE×2 | PHARMOBEDIENT | ANDA 061505 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE | PUREPAC PHARM | ANDA 061743 | — | Approved Prior to Jan 1, 1982 | |
| ERYTHROMYCIN STEARATE×2 | WATSON LABS | ANDA 062121 | — | Approved Prior to Jan 1, 1982 | |
| ETHRIL 250×2 | BRISTOL MYERS SQUIBB | ANDA 061605 | — | Approved Prior to Jan 1, 1982 | |
| PFIZER-E×2 | PFIZER | ANDA 061791 | — | Approved Prior to Jan 1, 1982 | |
| WYAMYCIN S×2 | WYETH AYERST | ANDA 061675 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Erythromycin stearate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
